Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty (NCT05898087) | Clinical Trial Compass
RecruitingPhase 4
Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty
United States128 participantsStarted 2022-04-01
Plain-language summary
The main question this randomized control trial aims to answer is:
ā¢ Is the use of intraoperative subpectoral bupivacaine associated with decreased post-operative pain in adolescent patients who undergo bilateral reduction mammaplasty
Participants will be randomized into the study group that intraoperatively receives 30cc of subpectoral bupivacaine injections or into the control group that intraoperatively receives 30cc of injectable saline subpectorally. All participants will keep a pain log and pain medication log at home for the first week following surgery.
Researchers will compare to see if patients who receive subpectoral bupivacaine have lower pain scores in the PACU, and lower use of narcotics post-operatively when compared to the control group who receive injectable saline.
Who can participate
Age range13 Years ā 25 Years
SexALL
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Inclusion criteria
ā. Female
ā. Age 13-25 at the time of surgery
ā. Undergoing bilateral reduction mammaplasty at Connecticut Children's from 1/1/2022-12/31/2025.
ā. Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.
Exclusion criteria
ā. Patients with history of substance use disorder or "chronic pain" defined as pain requiring management and treatment by a pain management specialist.
ā. Patients already taking narcotics at the time of surgery.
ā. Patients with a history of hepatic or renal dysfunction.
ā. Patients with known allergy to bupivacaine.
ā. Patients who are pregnant, determined by urine testing in pre-operative area.
ā. Patients who are non-verbal or have developmental delays that would result in inability to report reliable pain scores.